Howmedica Osteonics Corp. recalls TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

Stryker notified consignees on about 05/19/2026 via letter sent using FedEx 2-day service. Consignees were instructed to inform users of the Urgent Medical Device Recall and forward the notice to all individuals who need to be made aware or organizations who have consigned product, immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are on hand, and complete and return the provided Urgent Medical Device Recall Business Reply Form.

• FDA enforcement recordOfficial FDA database entry for Z-2462-2026
• FDA 510(k) clearance · K123486The device's official FDA premarket clearance record
• FDA device classification · MBHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3565The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Howmedica Osteonics Corp.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.